Signaling a possible future approach to regulating Schedule II-V prescribing via telemedicine in lieu of in-person examinations, on January 17 the DEA issued a notice of proposed rulemaking regarding its next iteration of controlled substance prescribing controls. With comments due March 18, 2025, the Proposed Rule is not subject to the Trump administration’s executive order freeze on new proposed regulations.
In-person physician examinations of hospice patients have long presented challenges rooted in hospice and palliative care practice standards and the lack of a Medicare requirement under the hospice benefit for an in-person physician evaluation. In the last few years, including as recently as November 14, 2024, the Drug Enforcement Administration (DEA) has issued a string of temporary rules extending COVID-19 public health emergency flexibilities through December 31, 2025 that permit the prescribing of controlled substances through telemedicine encounters without an in-person patient examination.
This proposed rule and its “special registration” process was authorized under a 2008 federal law, the Ryan Haight Online Pharmacy Consumer Protection Act which, at its core, was intended to regulate internet prescribing of controlled substances. The Ryan Haight Act generally requires an in-person medical evaluation prior to prescribing controlled substances over the internet, but carves out seven exceptions, including one for public health emergencies such as the COVID-19 pandemic, to allow for controlled substance prescribing via a telemedicine visit.
This most recent rulemaking effort is not the first time DEA has proposed rules for use of telemedicine for prescribing controlled substances, but those prior rulemaking efforts, including a proposed special registration process, faced stiff industry resistance. In each prior case, the proposals have either been rescinded by DEA or did not clear the Office of Management and Budget review process.
Now, in its latest attempt, DEA published its proposed Special Registrations for Telemedicine and Limited State Telemedicine Registrations rule in the Federal Register on January 17, 2025. Although the proposed rule would affect a broad swath of controlled substance prescribers, if finalized, it could have a profound effect on hospice and palliative care physicians’ use of telemedicine to prescribe controlled substances, as well as other practitioners including physicians who focus their practices in long-term care facilities. This article calls out the proposed rule’s potential effects on hospice, in particular.
In its simplest terms, the proposed rule would require a new Special Registration framework and authorize three types of special registrations for prescribers of controlled substances who treat patients through telemedicine without first having an in-person exam. The DEA’s proposed rule would specifically require hospice physicians and palliative care physicians, among others, to obtain an Advanced Telemedicine Prescribing Registration to prescribe Schedule II-V drugs pursuant to a telemedicine encounter.
This proposed rule would require heightened registration, prescription, recordkeeping, and reporting requirements for the Special Registration clinical practitioners. DEA believes such changes are necessary to effectively expand patient access to controlled substance medications via telemedicine while mitigating the risks of diversion associated with such expansion.
Notwithstanding the DEA’s goal to allow for controlled substance prescribing via telemedicine methods when balancing risks associated with opioid abuse and diversion, we anticipate significant physician and hospice industry opposition to the DEA proposed rule. In fact, the American Telemedicine Association (ATA) has released a statement urging President Trump to withdraw the rule, asserting that the proposed rule creates “major setbacks” due to “unworkable restrictions [that] could not be operationalized.”
We encourage various constituencies to examine the DEA proposal and submit public comments by the March 18 deadline given the significant legal, compliance, and documentation burdens associated with the proposed rule.
The proposed rule creates the Advanced Telemedicine Prescribing Registration (ATP Registration) process which authorizes certain prescribers with particular clinical need and specialized training to prescribe Schedule II–V controlled substances via telemedicine. The ATP Registration would involve the submission and approval of a special application form to DEA and would need to be renewed every three years (the same period applicable to current practitioner-controlled substance registrations).
More specifically, under its proposed rule, DEA lists the following types of physicians and mid-level practitioners as eligible for the ATP Registration:
The proposed rule requires the aforementioned clinician practitioners to furnish information in their ATP Registration applications demonstrating specialized training (e.g., board certification, specialized education, or the percentage of their overall practice that falls within one of the specialized practices).
While the DEA rule, if finalized, might provide a bright line for hospice physicians prescribing Schedule II narcotics via telemedicine, the proposal, depending on DEA’s interpretation, portends to upend the hospice industry with profound effects on providers’ operations.
Community physicians who continue to serve as attending physicians to hospice patients but who are not themselves hospice physicians, palliative care physicians, or practitioners who render treatment at LTC facilities may be ineligible for the ATP Registration. However, a community attending physician would presumably have an established physician-patient relationship stemming from an in-person evaluation and if prescribing for a legitimate medical purpose in the usual course of professional practice, the attending physician can continue to prescribe controlled substances for their patients, including Schedule II drugs.
However, community attending physicians have become increasingly resistant to prescribing controlled substances to hospice patients, particularly Schedule II drugs, for a variety of reasons. This DEA proposed rule may reinforce that resistance. Consequently, the burden of prescribing controlled substances, including pain medication, will continue to be more heavily borne by hospice medical directors and hospice physicians.
Hospice physicians, who often do not conduct in-person patient evaluations as part of traditional hospice care and who often do not conduct two-way audio-video medical exams, may need to change their practices if the proposed rule is finalized as written. Under the ATP Registration proposal, Schedule III-V controlled substances can only be teleprescribed following an audio-video examination of the patient, unless the patient is unable to use video or does not consent to video use.
For Schedule II drugs, ATP Registration practitioners could only prescribe via a telemedicine encounter for patients located in the same state at the time of the encounter. If the hospice physician has not previously established a physician-patient relationship (either via an in-person exam or telemedicine exam), the hospice physician would be unable to prescribe controlled substances for the hospice patients.
Consequently, depending on DEA’s interpretation of hospice physicians’ practice, obtaining an ATP Registration may effectively become a requirement to provide necessary hospice care which typically involves the prescribing of medically indicated Schedule II-V drugs. As such, maintaining a valid ATP Registration could also become a contractual obligation for hospice physicians with their respective hospices.
Though many hospice physicians who prescribe Schedule II–V drugs will qualify for the ATP Registration, the burdens of applying, obtaining, and maintaining the ATP Registration from DEA could be a substantial additional cost borne by hospices. There will be ancillary costs to hospice physicians, including requirements to obtain State Telemedicine Registrations, another DEA-issued registration. The ATP Registration fee will be $888 (the same fee as the three-year fee for typical practitioner DEA registrations), plus reduced fees of $50 for State Telemedicine Registration.
The ATP Registration application Form 224S would be accompanied by various disclosures and attestations that physician applicants may find burdensome or intrusive, including an attestation that they have devised, and are committed to maintaining, anti-diversion policies and procedures. The proposed rule would obligate ATP Registration holders to submit a Form 224S-M to make modifications to their ATP Registration within 14 business days of any such change, yet another burdensome obligation. Collectively, these burdensome ATP Registration processes and reporting obligations alone may cause certain physicians to forgo or reconsider working in the hospice setting.
Additional requirements will include mandatory checks of relevant prescription drug monitoring program (PDMP) databases before the issuance of any prescription for controlled substance to a patient via telemedicine. After an initial three-year period involving searching just the relevant state PDMP, the PDMP check would be expanded to the PDMPs of all 50 US states as well as any district or territory that maintains its own PDMP, should such a nationwide system check become available.
Other burdens in the proposed rule include:
On January 20, 2025, President Trump issued a number of executive orders and memoranda, including an executive order pausing all proposed regulations not yet published in the Federal Register. Because the DEA’s proposed rule was published in the Federal Register on January 17, 2025, this proposed rule won’t be subject to the regulatory freeze and will remain open for public comment. At present, without additional governmental intervention, comments are due no later than 11:59 pm ET on March 18, 2025.
At bottom, the DEA’s proposed rule, if finalized, would effectively either require hospice physician in-person examinations of hospice patients prior to prescribing Schedule II-V drugs or the use of the ATP Registration and telemedicine prescribing process. If history is a guide, in-person hospice physician evaluations can sometimes present practical challenges especially for hospice patients on service for a short period of time. Consequently, close consideration of the burdens of the proposed rule’s hospice physician ATP registration process is prudent. Filing timely comments with the agency will be critical to inform the DEA about the rule’s impact.
On January 21, President Trump announced that former Career Special Agent Derek Maltz has been appointed to serve as the DEA Administrator, and until his confirmation, will act as the Acting Administrator following Anne Milgram’s departure from the DEA earlier in January. Maltz served for 28 years at DEA before retiring in 2014, and subsequently served in other leadership capacities as Chief of the New York Drug Enforcement Task Force and in the private sector. It remains to be seen whether Acting Administrator Maltz will embrace, revise, or retract the rule as proposed.
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